Cognitive strategy training in Post-COVID-19 Syndrome: A feasibility trial.

COVID-19 后综合症的认知策略培训：可行性试验。

• 批准号: 10712171
• 负责人: Anna Boone
• 金额: $ 43.04万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712171
• 关键词: Achievement; Activities of Daily Living; Address; Area; Attention; Automobile Driving; Back; COVID-19; COVID-19 impact; COVID-19 long hauler; COVID-19 pandemic; COVID-19 survivors; Chi-Square Tests; Chronic; Classification; Client; Clinical Trials; Cognition; Cognitive; Communities; Compensation; Complex; Confidence Intervals; Control Groups; Coronavirus Infections; Data; Economics; Educational Intervention; Eligibility Determination; Etiology; Evidence based practice; Executive Dysfunction; Family; Foundations; Future; Goals; Habits; Health; Impaired cognition; Impairment; Improve Access; Individual; Infection; Intervention; Learning; Leisures; Life; Long COVID; Long-Term Effects; Measures; Medical; Medical center; National Institute of Child Health and Human Development; Neurobehavioral Manifestations; Neurologic; Occupational; Occupational activity of managing finances; Outcome; Outcome Measure; Outcome Study; Participant; Performance; Persons; Population; Preparation; Prevalence; Problem Solving; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Rehabilitation therapy; Reporting; Research; Research Priority; SARS-CoV-2 infection; Sample Size; Sampling; Self Management; Single-Blind Study; Stroke; Structure; Subgroup; Surveys; Symptoms; Task Performances; Testing; Time; Training; Traumatic Brain Injury; United States; Work; brain fog; cancer-related cognitive impairment; cognitive function; cognitive performance; cognitive recovery; coronavirus disease; dosage; effective intervention; executive function; experience; feasibility trial; functional improvement; improved; improved outcome; innovation; interest; intervention effect; meetings; mild traumatic brain injury; negative affect; novel; persistent symptom; post intervention; prevent; primary outcome; programs; recruit; rehabilitation research; rehabilitation service; remote administration; response; screening; secondary outcome; statistics; symptom management; symptomatology; treatment group; two-arm study

Project Summary/Abstract The long-term goal of this project is to help improve recovery from cognitive impairment associated with post- COVID-19 syndrome (PCS). PCS cognitive symptoms require the rehabilitation community to investigate ways to: (1) reduce the functional impact of the symptoms on daily life and (2) support individuals with PCS to establish new habits to improve and maintain health. The research hypothesis is that an activity-based metacognitive-strategy training intervention, the Cognitive Orientation to daily Occupational Performance (CO- OP) approach can feasibly be administered remotely and will improve activity performance, cognitive function, and quality of life in individuals with PCS. The specific aims of this study are to assess the: (1) feasibility of delivering CO-OP remotely to individuals with PCS in preparation for a future R01 trial; and (2) effect of CO-OP on activity performance, subjective and objective cognitive function, and quality of life in a sample of individuals with PCS as compared to an inactive control group. Specific aims will be completed through a single-blind, parallel, exploratory, randomized controlled trial. Individuals with PCS will be identified and asked to complete a prescreening survey to evaluate eligibility. Those meeting eligibility will undergo a baseline assessment battery. Participants (n=65) will then be randomized to a remote CO-OP treatment group (45 minutes per week for 10 weeks) or to an inactive control group. A post-intervention assessment will be completed immediately following the intervention. The purpose of this R21 is to evaluate feasibility outcomes and to obtain estimates of effect and precision of response on the outcome measures. To explore the effects of dosage on the primary outcome of activity performance, the biweekly COPM ratings will be plotted against time. Independent samples t-test and chi square test will be used to investigate differences among the two study arms and to assess whether randomization was successful. Descriptive statistics will be calculated for demographic information and the measures of intervention acceptability. Pre-to-post change in each of the outcome measures will be calculated for both groups. Cohen’s d effect size reported with precision around the estimate, 95% confidence intervals, will be used to evaluate the within and between group effects of the interventions on the primary and secondary outcome measures. The expected outcomes of this study are: (1) data to support the feasibility of remotely administering CO-OP; and (2) data to estimate effect sizes and precision of estimates of the CO-OP intervention in PCS. These data will be important for planning a future clinical trial to confirm any effects. This proposal is timely and consistent with the research priority of the National Center for Medical Rehabilitation Research (NCMRR) to identify, prevent, and treat key secondary conditions (e.g. PCS); the research program area of chronic symptom management; and the NICHD Notice of Special Interest (NOT-HD-20-03) addressing rehabilitation needs of COVID-19 survivors.

项目摘要/摘要 该项目的长期目标是帮助改善与术后相关的认知障碍的恢复 新冠肺炎综合征(PCS)。PCS认知症状需要康复社区调查方法 以：(1)减少症状对日常生活的功能影响和(2)支持PCS患者 养成改善和保持健康的新习惯。研究假设是以活动为基础的 元认知-策略培训干预，对日常工作绩效的认知定向 OP)方法可行，可以远程管理，并将改善活动表现，认知功能， 以及PCS患者的生活质量。这项研究的具体目的是评估：(1) 远程向患有PCS的个人提供CO-OP，为未来的R01试验做准备；以及(2)Co-OP的效果 抽样调查对象的活动表现、主客观认知功能和生活质量 与非活动对照组相比，有PCS的患者。具体目标将通过单盲法完成， 平行、探索性、随机对照试验。患有PCS的个人将被识别并被要求完成 为评估资格而进行的预先筛选调查。那些符合资格的会议将接受基线评估 电池。参与者(n=65)随后将被随机分配到远程CO-op治疗组(每周45分钟 10周)或给不活动的对照组。干预后评估将立即完成 在干预之后。本R21的目的是评估可行性结果并获得估计 反应的效果和精确度对结果测量的影响。探讨不同剂量对原发灶的影响 活动表现的结果，每两周的COPM评级将与时间相对应。独立样本 将使用t检验和卡方检验来调查两个研究分支之间的差异，并评估 随机化是否成功。将为人口统计信息计算描述性统计 以及干预可接受性的衡量标准。每项成果衡量标准的前后变动将是 两组均计算。科恩的d效应大小报告与估计的精确度大致相同，95%的置信度 间隔时间，将用于评估干预措施对初级和初级保健服务的组内和组间效果 次要结果衡量标准。这项研究的预期结果是：(1)数据支持 远程管理CO-OP；以及(2)用于估计CO-OP的效应大小和估计精度的数据 对PCS的干预。这些数据对于计划未来的临床试验以确认任何效果将是重要的。这 建议及时，与国家医疗康复中心的研究重点一致 识别、预防和治疗关键继发性疾病(如PCS)的研究(NCMRR)；研究计划 慢性症状管理领域；以及NICHD特别关注的通知(NOT-HD-20-03) 新冠肺炎幸存者的康复需求。